Akeso Biopharma Co., Ltd.
Form 483 issued August 7, 2023 · Zhongshan, China
- Observations
- 8
- Pages
- 12
- FEI number
- 3017057933
In short: On August 7, 2023, FDA issued a Form 483 with 8 observations to Akeso Biopharma Co., Ltd. in Zhongshan, Guangdong (FEI 3017057933). Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.100 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has not adequately validated your manufacturing processes for rug substance (DS) and drug product…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Your manufacturing control strategy does not adequately control for the potential introduction of adventitious agents from…
- 04
Your manufacturing control strategy and procedures are inadequate to prevent cross-contamination and product mix-up from all…
This inspection in context
Questions about this 483
What did FDA find at Akeso Biopharma Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Akeso Biopharma Co., Ltd. inspected by FDA?
This Form 483 is dated August 7, 2023.
How do I get the full Form 483 for Akeso Biopharma Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.